FDA EIR - Rockwell Medical, Inc - April 03, 2015

An FDA inspection of Rockwell Medical, Inc.'s Wixom, MI facility was conducted from February 17 to April 3, 2015. This was a routine Level II surveillance inspection, governed by the "Compliance Program Guidance Manual for Inspection of Medical Device Manufacturers" and "Guide to Inspections of Quality Systems, QSIT," alongside 21 CFR Part 820 Quality System Regulations. The inspection primarily focused on the firm's Class II medical devices, specifically liquid hemodialysis concentrates under the CitraPure brand, and evaluated Design Controls, Corrective and Preventive Actions (CAPA), and Production and Process Controls. The inspection identified significant violations, leading to the issuance of a six-item FDA-483 "Inspectional Observations." Key issues included a lack of product validation, inadequate equipment cleaning validation, and deficiencies in vendor controls for production equipment. Furthermore, the company failed to maintain written Design History File (DHF) procedures and supporting documentation for critical design control elements such as design validation, verification, reviews, and transfers. Concerns were also raised regarding the potential absence of 510(k) submissions for CitraPure formulation changes and insufficient design validation and stability data to substantiate product expiration claims. Notably, previous inspections at Rockwell Medical's various sites had repeatedly cited similar quality system deficiencies. Management acknowledged the observations and pledged to submit a written response to the Detroit District office.